Matt is a Pharmacovigilance Manager and the Veeva Vault Safety Implementation Lead. Having formerly managed the Bionical Emas Case Management Team, Matt has supported our clients with their case processing requirements over the last 5 years. Matt is highly committed to processing accurate data into the safety database and remaining compliant with global regulatory requirements.
As Implementation Lead, Matt is responsible for working with Veeva and the Bionical Emas Implementation Team to successfully launch Veeva Vault Safety.
The Bionical Emas Pharmacovigilance Team handle safety data from all phases of clinical studies, Early Access Programs (EAP) and authorised products from all corners of the globe. Matt and the team are constantly reviewing geopolitical and regulatory changes that will impact how we process client data whether it be from North America to Europe or beyond. With Vault Safety we have an agile safety database that ensures case processing activities; intake/triage, duplicate checks, data entry, quality control (QC), medical review, client review and regulatory submissions are all performed in a linear database workflow.
There are several activities running in tandem to ensure the successful launch of a safety database. Configuration, validation, migration and training are vital pillars in the implementation process. Matt ensures regular communication with the Veeva and Bionical Emas Implementation Teams to provide all the information required for Veeva to configure the Bionical Emas Vault Safety database, that all validation and migration activities are executed, and user training is performed prior to Vault Safety production “Go-Live.”
Veeva Vault Safety is a modern cloud based system that will enable Bionical Emas Pharmacovigilance to bring time efficiencies and increased quality to processing data. Matt works in close collaboration with the Veeva Team to maximise the existing functions within Vault Safety and collaborates with Veeva to ensure new features are included in future upgrades.
Looking ahead, Bionical Emas are excited to combine both Veeva Vault Safety and Vault EDC solutions through “Safety Link” which provides clients with a streamlined solution connecting data from Veeva Vault EDC into Veeva Vault Safety. Enabling enhanced transparency and consistency between data entered into the clinical and safety databases of adverse events arising from clinical trials with an ever increasing safety report load.